Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective Response Rate (Percentage of Participants With Complete Response [CR] or Partial Response [PR]): Independent Review Committee Assessment

Outcome Description:

Percentage of participants with objective response based assessment of confirmed CR or confirmed PR by the Independent Review Committee, according to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.0). CR was defined as the disappearance of all target and nontarget lesions and no appearance of new lesions. PR was defined as at least a 30% decrease in the sum of the longest diameters of the targeted lesions. CR and PR had to be documented on 2 occasions separated by at least 4 weeks.

Outcome Time Frame:

Up to 765 days of treatment at the data cut-off date

Safety Issue:

No

Principal Investigator

Pfizer CT.gov Call Center

Investigator Role:

Study Director

Investigator Affiliation:

Pfizer

Authority:

Japan: Ministry of Health, Labor and Welfare

Study ID:

A4061035

NCT ID:

NCT00569946

Start Date:

December 2007

Completion Date:

October 2012

Related Keywords:

• Carcinoma, Renal Cell
• AG-013736
• RCC
• Phase 2
• Carcinoma
• Carcinoma, Renal Cell